Abstract
ObjectivesThe study aim was to evaluate the impact on Liver and Kidney toxicity of the single tablet regimen Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) on Antiretroviral Therapy (ART) experienced or naïve patients.MethodsPatients initiating EVG/COBI/FTC/TDF were enrolled in the SCOLTA project, a multicenter observational study reporting grade 3–4 Adverse Events in subjects beginning new antiretroviral drug regimens. In this analysis, patients were evaluated at T0 (baseline), T1 (six months) and at T2 (twelve months).ResultsA total of 329 patients were enrolled, and 280 (85.1%) of these had at least one follow-up visit. Median observation time was 11 months (IQR 7.0–15.5). Two hundred and two patients (72.1%) were ART experienced and 78 (27.9%) ART naive. Prevalence of HCV-co-infection was 21.4%. At T1, we observed a significant decline in estimated glomerular filtration rate (eGFR), both in experienced and naive patients (mean change from T0–7.5 ± 12.8 ml/min, -15.5 ± 17.8 ml/min, respectively, p = 0.0005), which was confirmed at T2 (mean change from T0–8.2 ± 15.8 ml/min, -17.6 ± 19.4 ml/min, respectively, p = 0.001). Regarding aspartate aminotransferase (AST) and alanine transaminase (ALT) grade 1–2 modifications, no significant differences were observed between experienced and naïve subjects, but an increased prevalence of abnormal liver function test was observed in patients with chronic HCV infection (p<0.001).ConclusionsA significant decline in eGFR was observed in patients initiating EVG/COBI/FTC/TDF in the first 6 months, with no significant worsening occurring at 12 months vs. 6 months of therapy. Patients with chronic HCV infection were at higher risk to develop abnormal liver tests.
Highlights
Most studies evaluating the safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir-Disoproxil fumarate (EVG/COBI/FTC/TDF) have described a significant reduction in estimated glomerular filtration rate during the first four weeks of treatment, and few changes through 48 weeks, both in naive and experienced patients [1,2,3,4,5]
At T1, we observed a significant decline in estimated glomerular filtration rate, both in experienced and naive patients, which was confirmed at T2
Regarding aspartate aminotransferase (AST) and alanine transaminase (ALT) grade 1–2 modifications, no significant differences were observed between experienced and naïve subjects, but an increased prevalence of abnormal liver function test was observed in patients with chronic HCV infection (p
Summary
Most studies evaluating the safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir-Disoproxil fumarate (EVG/COBI/FTC/TDF) have described a significant reduction in estimated glomerular filtration rate (eGFR) during the first four weeks of treatment, and few changes through 48 weeks, both in naive and experienced patients [1,2,3,4,5]. Elevations in alanine transaminase (ALT) and aspartate aminotransferase (AST) were observed less frequently during EVG/COBI/FTC/TDF treatment, compared to Tenofovir/ emtricitabine/efavirenz (TDF/FTC/EFV) and tenofovir/emtricitabine/atazanavir/ritonavir (TDF/FTC/ATV/r) regimens. Such events occurred in 15–17% of naive patients [1, 2] and 2% of experienced ones [4] on EVG/COBI/FTC/TDF, vs 31–34% of naive patients on TDF/FTC/ EFV [1], in 22% of those on TDF/FTC/ATV/r as their first line treatment [2] and in 1% of experienced patients on Protease Inhibitor regimens [4]. Insomnia and depression were reported in about 3–9% of patients[1,2,3,4] and skin rash was experienced only by 0.3–6.0% of patients [1, 2]
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